Master Medical Device Registration in Egypt

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About Course

Master Medical Device Registration in Egypt — From Dossier Preparation to Market Success

Are you ready to conquer one of the largest and most dynamic medical device markets in the Middle East? With a population of over 100 million, Egypt offers huge opportunities — and this course will take you on a hands-on journey to successfully register and place your medical devices in this high-potential market.

Why This Course is Unique:

  • Learn the practical, hands-on steps to prepare and submit your dossiers.

  • Discover Egypt’s market-specific exceptions and requirements.

  • Gain insights on building strong partnerships for smooth approvals.

  • Explore NODCAR’s specialized analysis procedures — a must-know for Class III devices.

  • Experience the journey through Egypt’s regulatory landscape — fast, practical, and full of actionable tips.

Fasten Your Seatbelt — Let’s Fly Back 7,000 Years!

Join this exciting, practice-driven course and become an expert in Egyptian medical device registration. From dossier preparation to renewal, you’ll gain the knowledge, tools, and confidence to navigate the market like a pro — all while exploring one of the world’s most fascinating and historically rich regions.

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What Will You Learn?

  • Introduction to Egyptian Drug Authority (EDA) and its regulatory system
  • Step-by-step registration process for medical devices
  • How to prepare a complete technical file
  • Class III device registration insights and best practices
  • Real-world preparation of actual dossiers
  • Navigate the NODCAR analysis process — Egypt’s unique testing institution
  • Stay up-to-date with regulatory updates and exceptions unique to Egypt
  • Understand the full lifecycle of medical devices — from classification to renewal

Course Content

Module 1: Introduction
Let's get introduced and master EDA

  • Introduction
    18:23

Module 2:The Regulatory System
In this section we will go deeper to the regulatory system , with actual submissions with the details of the documents, focusing on what is special with MOH Egypt

Module 3:Registration process
In this section we will prepare the medical devices submission dossiers that should go through either DPPC or CAPA as per the class of the medical device

Module 4:The Technical File
In this section we will participate the actual technical dossier to prepare it

Module 5: Registration of Class III Medical Devices
In this section we will cover the registration process of the high risk classes medical devices , combined products, could be classified as pharmaceuticals , all submitted with MOH Egypt through CAPA

Module 6: The Actual Dossier
In this section we will practice the actual dossier preparation

Module 7: NODCAR
In this section we will move from MOH of Egypt to the NODCAR for the sample analysis associated with the registration attaching the list of documents along with its copies required for NODCAR analysis

Module 8: MOH Circulars
In this closing session we will go through some circulars to keep up to date with the changes in this huge dynamic bulky market

Module 9: The Medevic Platform
The Medevic Platform for online submission

Module 10: NODCAR Analysis
In this section you will mastre the NODCAR nalsyis , requirements and Appliaction, plus GTIN enforcement , and the 3 new PV declarations required for the PV practicing of any medical device

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